CivaDerm(TM) Surface Therapy Pilot Study

July 18, 2022 updated by: CivaTech Oncology
This is a pilot study to determine the usefulness of new brachytherapy device that utilizes active components (palladium-103) of standard devices in a novel configuration, which may benefit basal cell and squamous cell carcinoma patients by providing conformal radiation therapy to the surface of the skin.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • subject signed informed consent
  • Confirmed superficial or nodular basal cell or squamous cell carcinoma
  • Biopsy proven on chest, stomach, back, arms, legs, feet (trunk and extremities)
  • >5 mm of residual tumor
  • tumors < 3 cm
  • Capable of complying with Patient Release Instructions

Exclusion Criteria:

  • Is unable or unwilling to comply with the protocol requirements
  • Pregnant or breast feeding
  • Metastases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Radioactive bandage applied to surface of the body worn for approximately one week.
Device: CivaDerm
radioactive bandage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
skin toxicity events
Time Frame: within 2 months of treatment
grade 3+ events
within 2 months of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dose delivered to target
Time Frame: 1 week
calculated radiation dose
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CivaTech Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

April 30, 2023

Study Registration Dates

First Submitted

July 16, 2020

First Submitted That Met QC Criteria

July 20, 2020

First Posted (Actual)

July 21, 2020

Study Record Updates

Last Update Posted (Actual)

July 19, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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